Device Classification Name |
antibodies, anti-cyclic citrullinated peptide (ccp)
|
510(k) Number |
K093954 |
Device Name |
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
Applicant |
Bio-Rad Laboratories |
BIOPLEX 2200 DIVISION |
5500 EAST SECOND ST |
BENICIA,
CA
94510
|
|
Applicant Contact |
Juang Wang |
Correspondent |
Bio-Rad Laboratories |
BIOPLEX 2200 DIVISION |
5500 EAST SECOND ST |
BENICIA,
CA
94510
|
|
Correspondent Contact |
Juang Wang |
Regulation Number | 866.5775
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2009 |
Decision Date | 08/24/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|